DESC:FIELD OF INVENTION
[0001] The present invention relates to pharmaceutical compositions. In particular, the present invention relates to a safe and optimized pharmaceutical composition comprising phyto-constituents for treatment, amelioration or prevention of erectile dysfunction. It further relates to a method of preparing the pharmaceutical composition.

BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the present invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Erectile dysfunction is a male sexual condition wherein the penis fails to get an erection or maintain erection for satisfactory sexual intercourse. It is common in men to get erectile dysfunction occasionally when they are stressed or undergoing relationship issues. However, erectile dysfunction can become a problem when it is recurring. Curing erectile dysfunction is necessary as it may result in lower quality of sex life, emotional concerns, compromised self-image, depression or problems in impregnation. It may also be a sign of some underlying health concern specifically linked to cardiovascular conditions. It is not a fatal disease, but it is essential to diagnose and treat erectile dysfunction.
[0004] Erection is caused by the rush of blood in the arteries of penis initiated by sexual thoughts or physical contact. An arousal is achieved by an interaction of brain, hormones, nerve supply, blood flow, emotions and muscles relaxation/contraction. Owing to this, erectile dysfunction may be caused due to number of reasons such as any injury, surgery or physical trauma, stress, age, side effects of medications, blockage of blood vessels, hormonal changes and abnormalities, smoking and substance abuse, or any underlying medical or psychological conditions.
[0005] Currently available treatments include non-invasive and invasive techniques. Non-invasive techniques are change in lifestyle, pharmacological interventions, psychological counseling, or use of vacuum devices. Invasive techniques include some surgical treatments. In pharmacological interventions, there are many medications comprising Rx (prescription) & OTC (over-the-counter or non-prescription) products. Further, significant efforts has been put forward towards finding new and improved compositions containing natural products, however, none of the current approaches/treatments seems to satisfy the existing needs, and are either proved ineffective or lead to serious long term side-effects.
[0006] There is, therefore, an unmet need in the art to develop a new and improved pharmaceutical composition for effectively treating/preventing erectile dysfunction without causing any side-effects. The present invention fulfils the existing needs, at least in part, and alleviates one or more shortcomings of the conventional compositions.

OBJECTS OF THE INVENTION
[0007] An object of the present invention is to provide a pharmaceutical composition for treatment, amelioration or prevention of erectile dysfunction.
[0008] It is an object of the present invention to provide a pharmaceutical composition that enhances stamina, stimulates genital nerves, and prolongs ejaculation and erection time.
[0009] It is an object of the present invention to provide a pharmaceutical composition that improves the sexual performance, libido and sperm count.
[00010] It is an object of the present invention to provide a pharmaceutical composition that is substantially devoid of any side-effects.
[00011] It is an object of the invention to provide a pharmaceutical composition that exhibits superior storage stability and synergistic activity /functional reciprocity.
[00012] It is an object of the invention is to provide a pharmaceutical composition that is easy to prepare and economical.
[00013] Another object of the present invention is to provide a method of preparing the pharmaceutical composition for treatment, amelioration or prevention of erectile dysfunction.
[00014] Other objects of the present invention will be apparent from the description of the invention herein below.

SUMMARY OF THE INVENTION
[00015] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in Detailed Description section. This summary is not intended to identify key features or essential features of the subject matter, nor is it intended to be used as an aid in determining the scope of the subject matter.
[00016] The present invention relates to the field of pharmaceutical composition. In particular, the present invention relates to a safe and optimized pharmaceutical composition comprising phyto-constituents for treatment, amelioration or prevention of erectile dysfunction. It further relates to a method of preparing the pharmaceutical composition.
[00017] An aspect of the present invention relates to a pharmaceutical composition for treatment, amelioration or prevention of erectile dysfunction and associated disorders, said composition comprising any or a combination of: a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale.
[00018] In an aspect, the pharmaceutical composition comprises a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale. In an embodiment, the composition further comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent,a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[00019] In an aspect, the pharmaceutical composition may comprise whole of Ginko biloba, whole of Chlorophytum borivilianum, whole of Cordiceps, whole of Zingiber Officinale, part of Ginko biloba, part of Chlorophytum borivilianum, part of Cordiceps, part of Zingiber Officinale, extract of Ginko biloba, extract of Chlorophytum borivilianum, extract of Cordiceps, extract of Zingiber Officinale, or combinations thereof. The part or extract may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, tubers, sap, bud and combinations thereof.
[00020] In another aspect, the present invention also relates to a pharmaceutical composition for treatment, amelioration or prevention of erectile dysfunction and associated disorders comprising any or a combination of a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli). In an embodiment, the composition comprises a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli).
[00021] In an aspect, the pharmaceutical composition further comprises a pharmaceutically acceptable excipient.
[00022] In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[00023] In an aspect, the pharmaceutical composition may comprise whole of Paris polyphylla, whole of Anacyclus pyrethrum, whole of Chlorophytum borivilianum, part of Paris polyphylla, part of Anacyclus pyrethrum, part of Chlorophytum borivilianum, extract of Paris polyphylla, extract of Anacyclus pyrethrum, extract of Chlorophytum borivilianum, or combinations thereof.
[00024] In an aspect, the pharmaceutical composition comprises: Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition.
[00025] In an aspect, the composition comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[00026] In a preferred aspect, the pharmaceutical composition comprises: Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; Microcrystalline cellulose (MCC) in an amount ranging between 8% and 14% by weight of the composition, wherein MCC is a bulking agent; CCS in an amount ranging between 1% and 5% by weight of the composition, wherein CCS is a disintegrating agent; PVP K30 in an amount ranging between 0.5% and 2% by weight of the composition, wherein PVP K30 is a binding agent; Magnesium stearate in an amount ranging between 1% and 4% by weight of the composition, wherein magnesium stearate is a lubricant; and Ethanol in an amount ranging between 0.05% and 0.2% by weight of the composition, wherein ethanol acts as solvent and preservative.
[00027] In a preferred aspect, the present invention relates to a granular powder filled capsule formulation, wherein the formulation comprises: Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; Microcrystalline cellulose (MCC) in an amount ranging between 8% and 14% by weight of the composition, wherein MCC is a bulking agent; CCS in an amount ranging between 1% and 5% by weight of the composition, wherein CCS is a disintegrating agent; PVP K30 in an amount ranging between 0.5% and 2% by weight of the composition, wherein PVP K30 is a binding agent; Magnesium stearate in an amount ranging between 1% and 4% by weight of the composition, wherein magnesium stearate is a lubricant; and Ethanol in an amount ranging between 0.05% and 0.2% by weight of the composition, wherein ethanol acts as solvent and preservative.
[00028] In another aspect, the present invention also relates to a method of preparing a pharmaceutical composition, wherein the process is a wet granulation method. In an embodiment, method of preparing a pharmaceutical composition includes the steps of:
a) taking Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition; and optionally, pass through a sieve;
b) mixing all the ingredients (except lubricant) to obtain a blend;
c) adding ethanol in required amount to the blend and mixing to obtain a wet blend;
d) obtaining a dough mass from the wet blend, and optionally, sifting the dough mass through a sieve;
e) drying the dough mass at a temperature range from about from 35°C to 50°C for about 15 to 100 minutes to obtain dried granules;
f) optionally, sifting the dried granules through a sieve; and
g) adding lubricant (or sieved lubricant) to the dried granules or the sieved dried granules (as the case may be) to obtain a granular powder.
[00029] In another aspect, the present invention also relates to a method of preparing a pharmaceutical capsule formulation, wherein the process is a wet granulation method. In an embodiment, method of preparing a pharmaceutical capsule formulation includes the steps of:
a) taking Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition; Microcrystalline cellulose (MCC) in an amount ranging between 8% and 14% by weight of the composition; CCS in an amount ranging between 1% and 5% by weight of the composition; PVP K30 in an amount ranging between 0.5% and 2% by weight of the composition; Magnesium stearate in an amount ranging between 1% and 4% by weight of the composition; and Ethanol in an amount ranging between 0.05% and 0.2% by weight of the composition; and optionally, pass through a sieve;
b) mixing all the ingredients (except magnesium stearate) to obtain a blend;
c) adding ethanol in required amount to the blend and mixing to obtain a wet blend;
d) obtaining a dough mass from the wet blend, and optionally, sifting the dough mass through a sieve;
e) drying the dough mass at a temperature range from about from 35°C to 50°C for about 15 to 100 minutes to obtain dried granules;
f) optionally, sifting the dried granules through a sieve; and
g) adding magnesium stearate (or sieved magnesium stearate) to the dried granules or the sieved dried granules (as the case may be) to obtain a granular powder, followed by mixing;
h) filling the granules from step g) in a capsule.
[00030] In yet another aspect, the present invention relates to a method of preparing the pharmaceutical composition for treatment, amelioration or prevention of erectile dysfunction and associated disorders.
[00031] In yet another aspect, the present invention provides a method for management of erectile dysfunction and associated disorders in a subject by administering a therapeutically effective amount of the pharmaceutical composition.
[00032] In yet another aspect, the associated disorders include(s) but not limited to premature ejaculation, low libido, oligospermia, low stamina, sexual anxiety, un-sustained erection and improper physiological functioning.
[00033] In yet another aspect, the present invention provides a method of management of erectile dysfunction and associated disorders in a subject by administering a pharmaceutical composition comprising any or a combination of: a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale.
[00034] In yet another aspect, the present invention provides a method of management of erectile dysfunction and associated disorders in a subject by administering a pharmaceutical composition comprising any or a combination of a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli).
[00035] Other aspects of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learnt by the practice of the invention.

DETAILED DESCRIPTION OF THE INVENTION
[00036] The embodiments herein and the various features and advantageous details thereof are explained more comprehensively with reference to the non-limiting embodiments that are detailed in the following description. Descriptions of well-known components and processing techniques are omitted to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of the ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
[00037] Unless otherwise specified, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions may be included to better appreciate the teaching of the present invention.
[00038] As used in the description herein, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[00039] As used herein, the terms “comprise”, “comprises”, “comprising”, “include”, “includes”, and “including” are meant to be non- limiting, i.e., other steps and other ingredients which do not affect the end of result can be added. The above terms encompass the terms “consisting of” and “consisting essentially of”.
[00040] As used herein, the terms “composition”, “blend”, or “mixture” are all intended to be used interchangeably.
[00041] The terms “weight percent”, “vol-%”, “percent by weight”, “% by weight”, and variations thereof, as used herein, refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition and multiplied by 100. It is understood that, as used here, “percent”, “%”, and the like are intended to be synonymous with “weight percent”, “vol-%”, etc.
[00042] The term ‘therapeutically effective amount’ used throughout the present invention denotes an amount sufficient to produce the desired effects without causing side-effects.
[00043] The term ‘management’ used throughout the present invention denotes treatment, prevention and amelioration of the condition.
[00044] The term, "subject" used throughout the present invention denotes an animal, preferably a mammal, and most preferably a human. The term "mammal" used herein refers to warm-blooded vertebrate animals of the class 'mammalia', including humans, characterized by presence of male reproductive organ (penis). The term mammal includes animals such as dog, rabbit, bear, fox, wolf, monkey, deer, mouse, pig and human.
[00045] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about”. Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.
[00046] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[00047] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[00048] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[00049] The present invention relates to the field of pharmaceutical composition. In particular, the present invention relates to a safe and optimized pharmaceutical composition comprising phyto-constituents for treatment, amelioration or prevention of erectile dysfunction. It further relates to a method of preparing the pharmaceutical composition.
[00050] Two key targets phosphordiesterase-5 (PDE5) and Nitric Oxide (NO) play a very important role in maintaining the erection of the male reproductive organ. NO is synthesized through the activity of nitric oxide synthase (NOS) enzymes that are expressed in the endothelium of arteries and neuronal cells. It stimulates the production of cyclic guanosine monophosphate (cGMP) and results in smooth muscle relaxation and vasodilation through the NO/cGMP pathway. Shortage of intracellular NO and/or cGMP may lead to erection dysfunction. Inventors of the present invention realized that retaining intracellular cGMP levels by inhibition of PDE5 enzyme activity and increase in NO release improves the erectile dysfunction in male. Accordingly, based on extensive experimentation and research, inventors of the present invention has arrived at an optimized synergistic compositions that increases the level of NO and cGMP to effectively treat erectile dysfunction without causing any significant side-effects. Surprisingly, the composition exhibits superior storage stability and synergistic activity /functional reciprocity.
[00051] The present invention relates to a pharmaceutical composition for treatment, amelioration or prevention of erectile dysfunction and associated disorders, said disclosure comprising any or a combination of: a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale.
[00052] In an embodiment of the present invention, the pharmaceutical composition for treatment, amelioration or prevention of erectile dysfunction and associated disorders comprises: a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale. In an embodiment, the composition further comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[00053] In an embodiment of the present invention, the pharmaceutical composition may comprise whole of Ginko biloba, whole of Chlorophytum borivilianum, whole of Cordiceps, whole of Zingiber Officinale, part of Ginko biloba, part of Chlorophytum borivilianum, part of Cordiceps, part of Zingiber Officinale, extract of Ginko biloba, extract of Chlorophytum borivilianum, extract of Cordiceps, extract of Zingiber Officinale, or combinations thereof. The part or extract may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, tubers, sap, bud and combinations thereof of the plant.
[00054] In an embodiment of the present invention, the extracts are hydroalcoholic extracts. Preferably hydroethanolic extracts.
[00055] In an embodiment of the present invention, the pharmaceutical composition is used for treatment, amelioration or prevention of erectile dysfunction and associated disorders comprising any or a combination of a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli). In an embodiment, the composition for treatment, amelioration or prevention of erectile dysfunction and associated disorders comprises a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli).
[00056] In an embodiment of the present invention, the pharmaceutical composition further comprises a pharmaceutically acceptable excipient.
[00057] In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[00058] In an embodiment of the present invention, the pharmaceutical composition may comprise whole of Paris polyphylla, whole of Anacyclus pyrethrum, whole of Chlorophytum borivilianum, part of Paris polyphylla, part of Anacyclus pyrethrum, part of Chlorophytum borivilianum,extract of Paris polyphylla, extract of Anacyclus pyrethrum, extract of Chlorophytum borivilianum, or combinations thereof.
[00059] In an embodiment of the present invention, the part or extract of Paris polyphylla is the root; the part or extract of Anacyclus pyrethrum is the rhizome and the part or extract of Chlorophytum borivilianum is the root.
[00060] In an embodiment of the present invention, the pharmaceutical composition preferably comprises entire nutmeg, or nutmeg in powdered form. Preferably the nutmeg is present as nutmeg oil.
[00061] In an embodiment of the present invention, the associated disorders include(s) but not limited to premature ejaculation, low libido, oligospermia, low stamina, sexual anxiety, un-sustained erection and improper physiological functioning.
[00062] Ginko biloba or commonly called Maidenhair tree is a tree native to ancient China. It is deep-rooted with long erratic branches. It has been used as a source of food as well as medicine.
[00063] Chlorophytum borivilianumor Safed Musli is a herb native to India. It is a member of the asparagus family. It has been known for the treatment of diabetes and hypertension.
[00064] Cordiceps is a genus of ascomycete fungus, related to mushroom, deriving its name from Latin words cord meaning club and ceps meaning head. It is a parasite found in America, Europe as well as Asia.
[00065] Zingiber Officinale or ginger is a well known plant of the Zingiberaceae family which originated in Asia. It is an annual plant that bears purple-yellow flowers. Its thick, meaty rhizome has been used for culinary or medicinal purposes. Gingerols are the main active phyto-constituents of ginger.
[00066] Paris polyphylla (locally known as Satuwa/Satwa) is a perennial medicinal plant native to south-east Asia. It has a different structure with long-anthers bearing yellow flowers and leaves that form concentric circles below these flowers. The name of the plant comes from its multiple leaves- polyphylla. It has found usage in traditional medicine and veterinary applications.
[00067] Anacyclus pyrethrum (locally called akarkara) is a small perennial plant belonging to the Asteraceae family. The roots of the plant are aromatic and have a strong burning flavor. It has been used in the past for its antimicrobial and analgesic properties.
[00068] Chlorophytum borivilianum is a medicinal plant of India. It is commonly called Safed muslior white tuber after its nutrient rich roots. It is rich in several bioactives such as saponins, alkaloids, flavonoids, and vitamins.
[00069] Nutmeg is typically a spice made from the egg shapedseed of Myristica fragrans tree native to Banda islands of Indonesia. It was conventionally considered a precious spice typicallyused for its fragrance and culinary properties.
[00070] With regards extract of any or a combination of Ginko biloba, Chlorophytum borivilianum, Cordiceps, Ginseng, piperine, Zingiber Officinale, Paris polyphylla, Anacyclus pyrethrum, Nutmeg and Chlorophytum borivilianum commercially available extract thereof can also be used for realizing the composition of the present invention. Extracts may be available in concentrated liquid or dried powder form. However, extract prepared by any other method for isolation and extraction of active compounds, as known to or appreciated by a person skilled in the art, for example, maceration, soxhlet extraction, microwave-assisted extraction (MAE), ultrasound-assisted extraction (UAE), supercritical fluid extraction (SFE) and the likes can be used to serve its intended purpose, as laid down in the present invention without departing from the scope and spirit of the present invention.
[00071] In an embodiment of the present invention, the pharmaceutical composition of the present invention was realized using extracts procured from below-mentioned manufactures:
Table 1: Ingredients used:
S. NO. INGREDIENTS % OF ACTIVES VENDORS
1 Ginko biloba extract 24% gingko flavones Herbo Nutra,
UP, India
2 Chlorophytum borivilianum (Safed Musli) extract 40% saponins Herbo Nutra,
UP, India
3 Cordiceps extract Herbo Nutra,
UP, India
4 Ginseng extract 10% ginsenosides Herbo Nutra,
UP, India
5 Piperine 95%piperine Herbo Nutra,
UP, India
6 Zingiber Officinale (Ginger) extract 5% Herbo Nutra,
UP, India
9 Nutmeg extract Herbo Nutra,
UP, India

[00072] In an embodiment of the present invention, the bulking agent(s) include but not limited to, lactose USP, Starch 1500, mannitol, sorbitol, maltodextrin, malitol or other non-reducing sugars; microcrystalline cellulose (e.g., Avicel), dibasic calcium phosphate (anhydrous or dihydrate), sucrose, etc. and mixtures thereof. However, a person skilled in the art would appreciate that any other bulking agent(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00073] In an embodiment of the present invention, the solubilizer(s) includes but not limited to, cyclodextrins, pH adjusters, salts and buffers, surfactants, fatty acids, phospholipids, metals of fatty acids and the likes. However, a person skilled in the art would appreciate that any other solubilizing agent(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00074] In an embodiment of the present invention, the binder(s) include but not limited to, cellulosic derivatives (such as methylcellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, etc), polyacrylates (such as Carbopol, polycarbophil, etc), Povidone (all grades), Polyox of any molecular weight or grade, irradiated or not, maize starch, povidone, copovidone, corn starch, starch, polyvinylpyrrolidone (PVP), microcrystalline cellulose (Avicel@ -Avicel 101), and the like. However, a person skilled in the art would appreciate that any other binder(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00075] In an embodiment of the present invention, the glidant(s) includes but not limited to, colloidal silicon dioxide, precipitated silicon dioxide, fumed silica (CAB-O-SIL M-5P, trademark of Cabot Corporation), stearowet and sterotex, silicas (such as SILOID and SILOX silicas—trademarks of Grace Davison Products, Aerosil—trademark of Degussa Pharma), higher fatty acids, the metal salts thereof, hydrogenated vegetable oils and the like. However, a person skilled in the art would appreciate that any other glidant(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00076] In an embodiment of the present invention, the flavoring agent(s) includes but not limited to, fruit aromas such as orange, banana, strawberry, cherry, wild cherry, lemon; cardamom, anis, mint, menthol, vanillin, and ethyl vanillin, and other similar aromas such as coffee, or the mixtures thereof. However, a person skilled in the art would appreciate that any other flavoring agent(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00077] In an embodiment of the present invention, the sweetening agent(s) includes but not limited to, sucralose, acesulfame-K, aspartame, saccharine or saccharine sodium and calcium salts, sodium cyclamate, sucrose, fructose, glucose, sorbitol, or the mixtures thereof. However, a person skilled in the art would appreciate that any other sweetening agent(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00078] In an embodiment of the present invention, the buffer system includes but not limited to, sodium citrate, potassium citrate, sodium citrate di-hydrate, citric acid, citric acid monohydrate, sodium bicarbonate, potassium bicarbonate, sodium di-hydrogen phosphate and potassium di-hydrogen phosphate and the likes or combination thereof. However, a person skilled in the art would appreciate that any other buffer system can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00079] In an embodiment of the present invention, the disintegrant(s) includes but not limited to, croscarmellose sodium (CCS), Crospovidone, sodium, starch glyconate, citric acid, calcium carbonate, pregelatinized starch, Croscarmellose Sodium, ande and mixture thereof. However, a person skilled in the art would appreciate that any other disintegrant(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00080] In an embodiment of the present invention, the lubricant(s) includes but not limited to, zinc stearate, magnesium stearate, stearic acid, calcium stearate, Vegetable stearin and mixture thereof. However, a person skilled in the art would appreciate that any other lubricant(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00081] In an embodiment of the present invention, the diluent(s) includes but not limited to, microfine cellulose, lactose, starch, pregelatinized starch, calcium carbonate, calcium sulfate, sugar, dextrates, dextrin, dextrose, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, kaolin, magnesium carbonate, magnesium oxide, maltodextrin, mannitol, potassium chloride, powdered cellulose, sodium chloride, sorbitol, talc and mixture thereof. However, a person skilled in the art would appreciate that any other lubricant(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00082] In an embodiment of the present invention, the flavoring agent(s) includes but not limited to, fruit aromas such as orange, banana, strawberry, cherry, wild cherry, lemon; cardamom, anis, mint, menthol, vanillin, and ethyl vanillin, and other similar aromas, sodium benzoate or the mixtures thereof. However, a person skilled in the art would appreciate that any other flavoring agent(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00083] In an embodiment of the present invention, the preservative(s) includes but not limited to, p-hydroxybenzoic acid esters, sorbic acid, benzoic acid, propionic acid or salts thereof; Alcohols such as benzyl alcohol, butanol or ethanol, isopropyl alcohol and quaternary ammonium compounds such as benzalkonium chloride, sodium benzoate and mixture thereof. However, a person skilled in the art would appreciate that any other flavoring agent(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00084] In an embodiment of the present invention, the solvents includes but not limited to, methanol, ethanol, n-propanol, isopropanol, hexane, heptane, petroleum ether, cyclohexane, diethyl ether, diisopropyl ether, ethyl acetate, methyl acetate, ethyl formate, methyl formate, isobutyl acetate, n-butyl acetate, methylene chloride, ethylene chloride, chloroform, carbon tetrachloride, acetone, ethyl methyl ketone, diisobutyl ketone, methyl isobutyl ketone, 1,4- dioxane, toluene, ammonia solution, glacial acetic acid, ammonium hydroxide, sodium hydroxide, calcium hydroxide, calcium carbonate, potassium hydroxide, potassium carbonate, water and the likes. However, a person skilled in the art would appreciate that any other solvent or a combination of solvents can be utilized to serve the intended purpose without departing from the scope and spirit of the invention.
[00085] The pharmaceutical compositions detailed herein can be manufactured in one or several dosage forms. In an embodiment, pharmaceutical dosage form is selected from any or a combination of capsule, tablets or caplets; pills; powders such as a sterile packaged powder, a dispensable powder, and an effervescent powder; capsules including both soft or hard gelatin capsules such as HPMC capsules, lozenges, a sachet, a sprinkle, a reconstitutable powder or shake, a troche, granules, liquids such as suspensions, emulsions, semisolids, or gels. In an embodiment, the formulation may be in a solid, a liquid and a semi-solid form. However, any or a combination of pharmaceutical dosage form(s), as known to or appreciated by a person skilled in the art, can be utilized to serve its intended purpose, as laid in the present invention, without departing from the scope and spirit of the present invention.
[00086] In an embodiment of the present invention, the pharmaceutical composition is formulated into a granular powder. In an embodiment, the pharmaceutical composition is formulated into a capsule, a tablet, a pill, a powder and a sachet.
[00087] In an embodiment, the present invention provides a formulation comprising any or a combination of a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale.
[00088] In an embodiment, the formulation comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[00089] In an embodiment, the present invention provides a formulation comprising any or a combination of a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli).
[00090] In an embodiment of the present invention, the formulation comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[00091] In an embodiment of the present invention, the pharmaceutical composition may be administered orally and parenterally.
[00092] In an embodiment of the present invention, the pharmaceutical composition may be administered topically as spray, or dermal patches.
[00093] In an embodiment, the present invention relates to a medicament or food supplement comprising the composition.
[00094] In another embodiment, the present invention relates to a method of preparing a composition for treatment, amelioration or prevention of erectile dysfunction and associated disorders.In an embodiment, the present invention provides a method of management of erectile dysfunction and associated disorders in a subject by administering a pharmaceutical composition comprising any or a combination of a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale.
[00095] In an embodiment, the present invention relates to a method of management of erectile dysfunction and associated disorders in a subject by administering a pharmaceutical composition comprising any or a combination of a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli).
[00096] In an embodiment of the present invention, the pharmaceutical composition is safe, bio-available, exhibit synergistic effect without causing any significant side-effects on long-term usage.
[00097] In an embodiment of the present invention, the pharmaceutical composition increases the intracellular NO and cGMP amount, and inhibits PDE5 enzymatic activity. The composition effects instamina enhancement, stimulation of genital nerves, prolongation of erection (sustainment) and ejaculation time. It further improves sperm count, sexual desire (aphrodisiac), penile strength, sexual performance and satisfaction.
[00098] In an embodiment of the present invention, the pharmaceutical composition shows effective results in small time frame, in less than 8 weeks, preferably less than 6 weeks.
[00099] In another embodiment, the present invention also relates to use of a composition for management of erectile dysfunction.
[000100] In an embodiment, the present invention relates to use of a composition comprising any or a combination of a therapeutically effective amount of Ginko biloba, a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), a therapeutically effective amount of Cordiceps, a therapeutically effective amount of Ginseng, a therapeutically effective amount of piperine and a therapeutically effective amount of Zingiber Officinale, for management of erectile dysfunction and associated disorders.
[000101] In an embodiment, the present invention relates to use of a composition comprising any or a combination of a therapeutically effective amount of Paris polyphylla (Satuwa), a therapeutically effective amount of Anacyclus pyrethrum (Akarkara), a therapeutically effective amount of Nutmeg and a therapeutically effective amount of Chlorophytum borivilianum (Safed Musli), for management of erectile dysfunction and associated disorders.
[000102] In an embodiment of the present invention, the dosage of the composition may be determined by a medical practitioner based on the health of an individual, his medical history and severity of the condition.
[000103] In an alternate embodiment, the present invention provides all modes of administration, including subcutaneous, intramuscular, intraperitoneal, and/or intravascular injections.
[000104] In an embodiment of the present invention, the pharmaceutical composition may also be formulated in other dosage forms, including but not limited to drops, liquids, suspensions, semi-solids, solutions, syrups, gels, emulsions and the like.
[000105] In an embodiment of the present invention, the terms, “treatment”, “amelioration” or “prevention” as used herein refers to alleviate, slow the progression, attenuation, prophylaxis or as such treat the existing disease or condition. Treatment also includes treating, preventing development of, or alleviating to some extent, one or more of the symptoms of the diseases or condition.
[000106] In an embodiment of the present invention, the pharmaceutical composition comprises: Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition.
[000107] In an embodiment of the present invention, the formulation comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipients are selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[000108] In a preferred embodiment of the present invention, the pharmaceutical composition comprises: Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; Microcrystalline cellulose (MCC) in an amount ranging between 8% and 14% by weight of the composition, wherein MCC is a bulking agent; CCS in an amount ranging between 1% and 5% by weight of the composition, wherein CCS is a disintegrating agent; PVP K30 in an amount ranging between 0.5% and 2% by weight of the composition, wherein PVP K30 is a binding agent; Magnesium stearate in an amount ranging between 1% and 4% by weight of the composition, wherein magnesium stearate is a lubricant; and Ethanol in an amount ranging between 0.05% and 0.2% by weight of the composition, wherein ethanol acts as solvent and preservative.
[000109] In a preferred embodiment, of the present disclosure relates to a granular powder filled capsule formulation, wherein the formulation comprises: Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; Microcrystalline cellulose (MCC) in an amount ranging between 8% and 14% by weight of the composition, wherein MCC is a bulking agent; CCS in an amount ranging between 1% and 5% by weight of the composition, wherein CCS is a disintegrating agent; PVP K30 in an amount ranging between 0.5% and 2% by weight of the composition, wherein PVP K30 is a binding agent; Magnesium stearate in an amount ranging between 1% and 4% by weight of the composition, wherein magnesium stearate is a lubricant; and Ethanol in an amount ranging between 0.05% and 0.2% by weight of the composition, wherein ethanol acts as solvent and preservative.
[000110] In an embodiment, the present disclosure also relates to a method of preparing a pharmaceutical composition, wherein the process is a wet granulation method. In an embodiment, method of preparing a pharmaceutical composition includes the steps of:
a) taking Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition; and optionally, pass through a sieve;
b) mixing all the ingredients (except lubricant) to obtain a blend;
c) adding ethanol in required amount to the blend and mixing to obtain a wet blend;
d) obtaining a dough mass from the wet blend, and optionally, sifting the dough mass through a sieve;
e) drying the dough mass at a temperature range from about from 35°C to 50°C for about 15 to 100 minutes to obtain dried granules;
f) optionally, sifting the dried granules through a sieve; and
g) adding lubricant (or sieved lubricant) to the dried granules or the sieved dried granules (as the case may be) to obtain a granular powder.
[000111] In an embodiment, the present disclosure also relates to a method of preparing a pharmaceutical capsule formulation, wherein the process is a wet granulation method. In an embodiment, method of preparing a pharmaceutical capsule formulation includes the steps of:
i) taking Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition; Microcrystalline cellulose (MCC) in an amount ranging between 8% and 14% by weight of the composition; CCS in an amount ranging between 1% and 5% by weight of the composition; PVP K30 in an amount ranging between 0.5% and 2% by weight of the composition; Magnesium stearate in an amount ranging between 1% and 4% by weight of the composition; and Ethanol in an amount ranging between 0.05% and 0.2% by weight of the composition; and optionally, pass through a sieve;
j) mixing all the ingredients (except magnesium stearate) to obtain a blend;
k) adding ethanol in required amount to the blend and mixing to obtain a wet blend;
l) obtaining a dough mass from the wet blend, and optionally, sifting the dough mass through a sieve;
m) drying the dough mass at a temperature range from about from 35°C to 50°C for about 15 to 100 minutes to obtain dried granules;
n) optionally, sifting the dried granules through a sieve; and
o) adding magnesium stearate (or sieved magnesium stearate) to the dried granules or the sieved dried granules (as the case may be) to obtain a granular powder, followed by mixing;
p) filling the granules from step g) in a capsule.
[000112] In an embodiment, the size of the capsule may be 0, 00 or 000. In an embodiment, the size of the capsule is 00.
[000113] In an embodiment, the capsule formulation exhibits a shelf life of about 2 years.
[000114] In an embodiment of the present invention, the pharmaceutical compositions may be used along with other treatments for improvement in his condition. It may also be used or consumed as a part of food supplements or health drinks.
[000115] While the foregoing describes various embodiments of the invention, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
EXAMPLES
[000116] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present invention. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein.
EXAMPLE
[000117] Example 1: A pharmaceutical capsule formulation
TABLE 2: A Pharmaceutical Capsule Formulation
S. No. Ingredients Quantity in mg for 400 mg Capsule
1 Ginko biloba extract 50.00
2 Safed Musli extract 100.00
3 Cordiceps extract 30.00
4 Ginseng extract 100.00
5 Piperine 5.00
6 Ginger extract 50.00
7 Microcrystalline cellulose 40.50
8 CCS 7.00
9 PVP K30 2.50
10 Magnesium stearate 15.00
11 Ethanol qs

[000118] Example 2: Method of preparing the pharmaceutical capsule formulation from Example 1
[000119] All the ingredients were weighed accurately as per Table 2 above. The ingredients were passed through sieve #40 one after the other. All the ingredients (except magnesium stearate) were properly mixed to obtain a blend and required amount of ethanol was added to the blend for granulation. The wet mass was thereafter sieved using sieve #10 to give a dough mass. The dough mass was dried at 40°C to 45°C for about 60 minutes. The obtained dried granules were then passed through sieve #18 to obtain granular powder. For lubrication, magnesium stearate was passed through sieve no #40, and was added to the above dried granules and mix for about 5 minutes. The granular powder was then filled into capsule of size 00 and was subjected to stability testing and measurement of efficacy. Surprisingly, the formulation of the present disclosure exhibited superior storage stability and functional reciprocity/strong synergy there between
[000120] The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

ADVANTAGES OF THE PRESENT INVENTION
[000121] The present invention provides a composition for treatment, amelioration or prevention of erectile dysfunction.
[000122] The present invention provides a composition that enhances stamina, stimulates genital nerves, and prolongs ejaculation and erection time.
[000123] The present invention provides a composition that improves the sexual performance, libido and sperm count.
[000124] The present invention provides a composition that is substantially devoid of any side-effects.
[000125] The present invention provides a composition that exhibits superior storage stability and synergistic activity /functional reciprocity.
[000126] The present invention provides a composition that is easy to prepare and economical.
[000127] The present invention provides a method of preparing the composition for treatment, amelioration or prevention of erectile dysfunction.

WE CLAIMS:

1. A pharmaceutical composition, said composition comprising:
Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition;
Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition;
Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition;
Ginseng extract in an amount ranging between 22% and 27% by weight of the composition;
Piperine in an amount ranging between 0.5% and 2% by weight of the composition;
Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and
one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition.
2. The composition as claimed in claim 1, wherein the pharmaceutically acceptable excipient is selected from any or a combination of a bulking agent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, a solvent and a co-solvent.
3. The composition as claimed in claim 1, wherein the binder is present in an amount ranging between 8% and 14% by weight of the composition.
4. The composition as claimed in claim 1, wherein the disintegrant is present in an amount ranging between 1% and 5% by weight of the composition.
5. The composition as claimed in claim 1, wherein the flavoring agent is present in an amount ranging between 0.5% and 2% by weight of the composition.
6. The composition as claimed in claim 1, wherein the lubricant is present in amount ranging between 1% and 4% by weight of the composition.
7. The composition as claimed in claim 1, wherein the composition is formulated in to a capsule.
8. A pharmaceutical composition as claimed in claim 1, said pharmaceutical composition comprising:
Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition;
Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition;
Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition;
Ginseng extract in an amount ranging between 22% and 27% by weight of the composition;
Piperine in an amount ranging between 0.5% and 2% by weight of the composition;
Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and
Microcrystalline cellulose (MCC) in an amount ranging between 8% and 14% by weight of the composition, wherein MCC is a bulking agent;
CCS in an amount ranging between 1% and 5% by weight of the composition, wherein CCS is a disintegrating agent;
PVP K30 in an amount ranging between 0.5% and 2% by weight of the composition, wherein PVP K30 is a binding agent; and
Magnesium stearate in an amount ranging between 1% and 4% by weight of the composition, wherein magnesium stearate is a lubricant.
9. A granular powder filled capsule formulation, said formulation comprising:
Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition;
Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition;
Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition;
Ginseng extract in an amount ranging between 22% and 27% by weight of the composition;
Piperine in an amount ranging between 0.5% and 2% by weight of the composition;
Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and
one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition.
10. A method for preparing the capsule formulation as claimed in claim 11, wherein the method is wet-granulation method comprising the steps of:
a) taking Ginko biloba extract in an amount ranging between 11% and 14% by weight of the composition; Safed Musli extract in an amount ranging between 22% and 27% by weight of the composition; Cordiceps extract in an amount ranging between 6% and 9% by weight of the composition; Ginseng extract in an amount ranging between 22% and 27% by weight of the composition; Piperine in an amount ranging between 0.5% and 2% by weight of the composition; Ginger extract in an amount ranging between 9% and 15% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 3% to 20% by weight of the composition; and optionally, pass through a sieve;
b) mixing all the ingredients (except magnesium stearate) to obtain a blend;
c) adding ethanol in required amount to the blend and mixing to obtain a wet blend;
d) obtaining a dough mass from the wet blend, and optionally, sifting the dough mass through a sieve;
e) drying the dough mass at a temperature range from about from 35°C to 50°C for about 15 to 100 minutes to obtain dried granules;
f) optionally, sifting the dried granules through a sieve; and
g) adding magnesium stearate (or sieved magnesium stearate) to the dried granules or the sieved dried granules (as the case may be) to obtain a granular powder, followed by mixing; and
h) filling the granules from step g) in a capsule.